What is a Clinical Trial?

A clinical trial is a research study that involves human beings. Clinical trials are a way to evaluate a new drug or treatment, and they are the final step in a long process that begins with research in a lab and animal testing. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. All of today's standard cancer treatments were first shown to be effective in clinical trials. New and better treatments for cancer will be discovered through the continued support of patients who participate in clinical trials.

Before a new treatment is tested with patients, it is carefully studied for several years in the laboratory and tested for safety. This research identifies the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. Then, clinical trials undergo a rigorous approval process both by the Federal Food and Drug Administration (FDA) and by several internal committees at Penn State Hershey Cancer Institute, Penn State Milton S. Hershey Medical Center and Penn State College of Medicine. Although there is always a possibility that a clinical trial will show disappointing results, the researchers and physicians who conduct a study and those members of the various review committees who approve the study have reason to believe that it will be as good as, or better than, current treatments.

Cancer clinical trials are designed to answer questions about:

Treating cancer

Diagnosing cancer

Preventing cancer

Managing symptoms of cancer or effects of treatment

Testing new therapies in patients is done through multiple phases of clinical trials. The early phases make sure the therapy is safe, and later phases provide information on how it works in comparison to standard treatment. The phases of clinical trials are briefly described below.

Phase I – Phase I studies are “first in human” trials. Here, we are looking for a safe dose of a new drug or therapy, at how the new treatment should be given, and how the new treatment affects the human body. Approximately 15-30 participants are enrolled on phase I studies.

Phase II – Phase II studies assess the safety and effectiveness of a new treatment on a certain cancer. During phase II, we are continuing to look at how the treatment affects the human body. Less than 100 participants are enrolled on phase II studies.

Phase III – Phase III studies compare a new treatment with the current standard therapy. In phase III trials we are continuing to look at the safety and effectiveness of the new treatment. Hundreds or thousands of participants are needed for phase III studies.

Phase IV – Phase IV studies further evaluate long-term safety and effectiveness of a new treatment. Several hundred to several thousand participants are enrolled on phase IV studies.

Penn State Hershey Cancer Institute has a long history of excellence in conducting clinical research and clinical trials. Through research and clinical trials, we have helped to advance the treatment of a number of cancers. We take great care to insure both scientific integrity and ethical conduct in all clinical trials.